Venetoclax: Additional Phase II data

Additional data from the open-label, international, pivotal Phase II M13-982 trial in 107 patients with relapsed or refractory CLL with the chromosome 17p deletion showed that once-daily 400 mg oral venetoclax led to an ORR, the primary endpoint, of 79.4%, including 8 complete responses (CRs) or complete responses with incomplete hematologic recovery (CRis), 3 nodular partial responses (PRs) and 74 PRs as assessed by an independent review committee (IRC). The ORR was 73.8% as assessed by investigators, including 17 CR/CRis, 4 nodular PRs and 58 PRs. Additionally, 18 patients had no detectable minimal residual disease (MRD) in peripheral blood. Median time to first response was 0.8 months and median time to CR/Cri was 8.2 months. Overall median duration of response, PFS and OS were not yet reached. Next month, data will be presented at the American Society of Hematology meeting in Orlando. ...